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临床试验/NCT06605300
NCT06605300已完成不适用

The Modulatory Effects of Oxytocin and Vasopressin on Delta-beta Cross-frequency Coupling

University of Electronic Science and Technology of China2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年10月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
2
主要终点
Resting-state EEG

研究概览

简要总结

The main aim of the study is to investigate whether intranasal oxytocin and vasopressin have effects on delta-beta cross-frequency coupling under resting-state and task conditions.

详细描述

A double-blinded, placebo-controlled, between-subject design is employed in this study. In a randomized order, a total of 120 healthy males and females are instructed to self-administer intranasal spray of oxytocin, vasopressin, or placebo. (1) 15-minute resting-state EEG data are collected 35 minutes after treatment. (2) Participants complete tasks including Stroop, GO/NOGO, and anxiety induction with behavioral (response time, accuracy, or rating) and EEG data being collected. Personality traits of subjects are assessed using validated Chinese version questionnaires including the Beck Depression Inventory (BDI-II), State-Trait Anxiety Inventory (STAI), Autism Spectrum Quotient (ASQ), and Adult ADHD Self-Report Scale (ASRS-v1.1). Participants are asked to complete Positive and Negative Affect Schedule (PANAS) when they just arrive, before resting state and after the tasks. Three blood samples (5 ml) are collected into 6 ml ETDA tubes when participants just arrive, before resting state recording and after all of the tasks.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy subjects without past or current psychiatric or neurological disorders.

排除标准

  • History of head injury.
  • Pregnant,menstruating,taking oral contraceptives.
  • Medical or psychiatric illness.

研究组 & 干预措施

vasopressin

Experimental

A single dose of 20 international units (IU) of vasopressin will be administered with 3 puffs of treatment to each nostril.

干预措施: Intranasal Vasopressin (AVP) (Drug)

oxytocin

Experimental

A single dose of 24 international units (IU) of oxytocin will be administered with 3 puffs of treatment to each nostril.

干预措施: Intranasal Oxytocin (IN-OXT) (Drug)

placebo

Placebo Comparator

A single dose of placebo will be administered with 3 puffs of treatment to each nostril.

干预措施: Intranasal Placebo (Drug)

结局指标

主要结局

Resting-state EEG

时间窗: 35-50 minutes after treatment administration.

Participants are asked to sit comfortably and look at a white cross fixation against a black background on the computer monitor for 15 minutes with delta-beta cross-frequency coupling as a main index.

Behavioral indices in the tasks

时间窗: 50-90 minutes after treatment administration.

Reaction time and accuracy are recorded in the emotional Stroop and Go/Nogo tasks. For the anxiety induction task, participants are instructed to rate their anxiety levels using a 9-point Likert scale within 4 seconds (1 = not at all, 9 = very anxious).

Task-based EEG

时间窗: 50-90 minutes after treatment administration.

EEG data are recorded in the emotional Stroop, Go/Nogo, and anxiety induction tasks. Delta-beta cross-frequency coupling will be calculated to do statistical analyses.

次要结局

  • SCR in anxiety induction(70-90 minutes after treatment administration.)

研究者

发起方
University of Electronic Science and Technology of China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Shuxia Yao

Associate Professor

University of Electronic Science and Technology of China

研究点 (2)

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